A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Study acronym: DUET ENCORE-UC
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Trial sites expanded: 170 → 279 locations
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 12 to 13
  2. Trial sites expanded: 63 → 170 locations
    • Study completion date: Oct 30, 2030 to Oct 16, 2030
    v5
  3. Trial sites expanded: 26 → 63 locationsv4
  4. Trial sites expanded: 6 → 26 locationsv3
  5. Recruitment opened
    • Trial sites expanded: 0 → 6 locations
    • Start date changed from estimate of May 29, 2026 to May 23, 2026
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).
Trial Details
NCT Number NCT07577856
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Colitis, Ulcerative
Related terms Colitis, Ulcerative
Enrollment 644 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov